阅读说明：本技术 一种真空采血管的辐照灭菌方法 (Irradiation sterilization method for vacuum blood collection tube ) 是由 邹伟权 彭志刚 王燕芳 胡振波 于 2020-12-21 设计创作，主要内容包括：本发明公开了一种真空采血管的辐照灭菌方法,包括如下步骤：S01：将真空采血管浸泡在抑菌溶液中；S02：将浸泡后的真空采血管烘干,使得真空采血管外表面形成一层抑菌膜；S03：对所述真空采血管进行包装；S04：将真空采血管运输至辐照腔室；S05：将包装后的真空采血管进行辐照灭菌,辐照灭菌的剂量为8-20kGy。本发明创造性地在真空采血管生产完成之后,在其表面涂覆抑菌膜,该抑菌膜可以很好地抑制真空采血管运输过程中外表面的微生物繁殖,进而保证同一批真空采血管在最佳剂量辐照下均能达到预设的灭菌效果,在涂覆抑菌膜的过程中可以同步检测真空采血管的密封性,淘汰掉密封性不好的真空采血管。(The invention discloses an irradiation sterilization method of a vacuum blood collection tube, which comprises the following steps: s01: soaking the vacuum blood collection tube in an antibacterial solution; s02: drying the soaked vacuum blood collection tube to form a layer of antibacterial film on the outer surface of the vacuum blood collection tube; s03: packaging the vacuum blood collection tube; s04: transporting the vacuum blood collection tube to an irradiation chamber; s05: and (4) carrying out irradiation sterilization on the packaged vacuum blood collection tube, wherein the irradiation sterilization dose is 8-20 kGy. According to the invention, after the vacuum blood collection tube is produced, the antibacterial film is coated on the surface of the vacuum blood collection tube, and the antibacterial film can well inhibit the propagation of microorganisms on the outer surface of the vacuum blood collection tube in the transportation process, so that the same batch of vacuum blood collection tubes can achieve a preset sterilization effect under the irradiation of the optimal dose, the sealing property of the vacuum blood collection tube can be synchronously detected in the process of coating the antibacterial film, and the vacuum blood collection tube with poor sealing property is eliminated.)

1. The irradiation sterilization method for the vacuum blood collection tube is characterized by comprising the following steps:

s01: soaking the vacuum blood collection tube in an antibacterial solution;

s02: drying the soaked vacuum blood collection tube to form a layer of antibacterial film on the outer surface of the vacuum blood collection tube;

s03: packaging the vacuum blood collection tube;

s04: transporting the vacuum blood collection tube to an irradiation chamber;

s05: and (4) carrying out irradiation sterilization on the packaged vacuum blood collection tube, wherein the irradiation sterilization dose is 8-20 kGy.

2. The method according to claim 1, wherein the step of completely soaking the vacuum blood collection tube in the bacteriostatic solution in step S01 is performed to synchronously detect the sealing performance of the vacuum blood collection tube.

3. The method of claim 2, wherein the soaked tubes are removed in step S01, and if the tube is filled with liquid, the tube does not meet the sealing performance, and the tube is determined to be an unqualified product.

4. The method according to claim 2, wherein the step S01 is performed by pressing the evacuated blood collection tube with a pressing plate into a liquid tank, keeping the pressure for 24-48h, and taking out the evacuated blood collection tube, wherein the liquid tank is filled with the bacteriostatic solution.

5. The method for radiation sterilization of evacuated blood collection tubes according to claim 1, wherein the immersed evacuated blood collection tubes are dried in an oven at 60-80 ℃ in step S02.

6. The method for radiation sterilization of evacuated blood collection tubes according to claim 1, wherein the bacteriostatic solution comprises the following components in parts by weight: 5-8 parts of bighead atractylodes rhizome extract, 5-8 parts of aloin, 0.5-1 part of silver sulfate, 2-4 parts of surfactant, 0.5-1 part of lactic acid and 78-87 parts of deionized water.

7. The method of claim 7, wherein the surfactant is polyvinylpyrrolidone.

8. The method for radiation sterilization of evacuated blood collection tubes according to claim 7, wherein the preparation method of the bacteriostatic solution comprises the following steps:

s01: adding Atractylodis rhizoma extract and aloin into deionized water, and stirring to obtain extractive solution;

s02: adding a surfactant and lactic acid into the extracting solution, and uniformly stirring;

s03: adding silver sulfate solution and stirring uniformly to form the antibacterial solution.

9. The method for radiation sterilization of evacuated blood collection tubes according to claim 1, wherein step S05 is performed by⁶⁰And performing irradiation sterilization by cobalt gamma rays.

Technical Field

The invention relates to the field of irradiation sterilization, in particular to an irradiation sterilization method for a vacuum blood collection tube.

Background

Vacuum blood collection tubes can cause biological hazards if not completely sterilized, such as: (1) the blood collection tube is not produced in a clean environment, so that particulate matters and microbial pollution are easily introduced, for example, bacterial endotoxin can have adverse effects on the test result of the endotoxin-free tube; (2) the process and the production environment in the preparation process of the vacuum blood collection tube are not proper, the purity of the used dissolved water does not meet the requirement, the product is not sterilized or does not reach the expected sterilization effect, and the team emblem causes the liquid in the blood collection tube to mildew; (3) the vacuum blood collection tube is not sterilized thoroughly, so that product pollution can be caused, and blood backflow occurs in the using process to cause septicemia of patients. 5 cases of sepsis in 1974, which occurred in 2 hospitals in Canada, were reported to occur in patients with blood reflux using non-sterile evacuated blood collection tubes.

With the gradual popularization of irradiation sterilization, the field of medical devices also gradually uses an irradiation sterilization process. The penetration of gamma ray and electron beam irradiation is strong, and the sterility guarantee level can reach 10^-6And the irradiation time is short, and the sterilization effect is obvious.

It is worth noting that the irradiation chambers are generally arranged in a concentrated manner, at a distance from the production site of the extracorporeal circulation circuit. Therefore, the vacuum blood collection tube is usually transported to the irradiation chamber for sterilization after the production is completed. Meanwhile, the mechanical performance requirements of disposable vacuum blood collection tubes are generally not very high, and if the irradiation dose is too large or the irradiation time is long, the performance of the vacuum blood collection tubes is affected. Therefore, the effectiveness of radiation sterilization in the prior art is established on the basis of standard sterilization process control, and the optimal dosage requirement of the vacuum blood collection tubes in the same production process is determined according to the requirements of GB 18280.2-2015 part 2 of sterilization radiation for medical and health care products to establish sterilization dosage (ISO 11137-2: 2006). For the optimal dose, if the propagation of microorganisms on the surface of the blood collection tube is transitional due to long transportation time and the like from the production of the vacuum blood collection tube to the irradiation sterilization and exceeds the set initial contamination level, the established sterilization dose will be invalid and the sterilization dose needs to be set again. However, setting of the sterilization dose requires a lot of time and process, and the propagation of microorganisms on the surface of the blood collection tube during transportation is uncertain, and thus the optimal dose of irradiation cannot be determined; if the optimal dose is set in advance, the same effect of sterilization cannot be achieved for all the vacuum blood collection tubes in the same batch.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a radiation sterilization method of a vacuum blood collection tube.

In order to achieve the purpose, the invention adopts the following technical scheme: a radiation sterilization method of a vacuum blood collection tube comprises the following steps:

s01: soaking the vacuum blood collection tube in an antibacterial solution;

s02: drying the soaked vacuum blood collection tube to form a layer of antibacterial film on the outer surface of the vacuum blood collection tube;

s03: packaging the vacuum blood collection tube;

s04: transporting the vacuum blood collection tube to an irradiation chamber;

s05: and (4) carrying out irradiation sterilization on the packaged vacuum blood collection tube, wherein the irradiation sterilization dose is 8-20 kGy.

Further, in step S01, the vacuum blood collection tube is completely immersed in the bacteriostatic solution, and the sealing performance of the vacuum blood collection tube is synchronously detected.

Further, the soaked vacuum blood collection tube is taken out in step S01, and if the vacuum blood collection tube is filled with liquid, the sealing performance of the vacuum blood collection tube does not reach the standard, and the vacuum blood collection tube is regarded as an unqualified product.

Further, in the step S01, the vacuum blood collection tube is completely pressed into the liquid tank by the pressing plate for 24-48 hours and then taken out, and the liquid tank is filled with the bacteriostatic solution.

Further, in the step S02, the soaked vacuum blood collection tube is dried in an oven at 60-80 ℃.

Further, the bacteriostatic solution comprises the following components in parts by weight: 5-8 parts of bighead atractylodes rhizome extract, 5-8 parts of aloin, 0.5-1 part of silver sulfate, 2-4 parts of surfactant, 0.5-1 part of lactic acid and 78-87 parts of deionized water.

Further, the surfactant is polyvinylpyrrolidone.

Further, the preparation method of the bacteriostatic solution comprises the following steps:

s01: adding Atractylodis rhizoma extract and aloin into deionized water, and stirring to obtain extractive solution;

s02: adding a surfactant and lactic acid into the extracting solution, and uniformly stirring;

s03: adding silver sulfate solution and stirring uniformly to form the antibacterial solution.

Further, the step S05 adopts⁶⁰And performing irradiation sterilization by cobalt gamma rays.

The invention has the beneficial effects that: according to the invention, after the production of the vacuum blood collection tube is completed, the surface of the vacuum blood collection tube is coated with the antibacterial film, and the antibacterial film can well inhibit the propagation of microorganisms on the outer surface of the vacuum blood collection tube in the transportation process, so that the same batch of vacuum blood collection tubes can achieve a preset sterilization effect under the irradiation of the optimal dose; secondly, the bacteriostatic membrane can ensure that the microorganism propagation on the outer surface of the vacuum blood collection tube is inhibited in the using process of the vacuum blood collection tube, so that cross contamination of medical workers in the operation process is prevented; finally, can detect the leakproofness of vacuum test tube in step at the in-process of coating antibacterial membrane, eliminate the vacuum test tube that the leakproofness is not good, further improve the detection efficiency of vacuum test tube.

Detailed Description

The invention will be further described with reference to specific embodiments:

the core idea of the invention is that: after the production of the vacuum blood collection tube is finished and before irradiation sterilization is carried out, coating a layer of antibacterial film on the outer surface of the vacuum blood collection tube; the bacteriostatic film has the following functions: (1) during the transportation process of the vacuum blood collection tube from the production base to the irradiation base, the propagation of microorganisms outside the vacuum blood collection tube is inhibited. The inside of the vacuum blood collection tube is in a vacuum environment, and the propagation of microorganisms can be inhibited, so that the propagation of the microorganisms in the vacuum blood collection tube is not too fast in the transportation process; the outer surface of the vacuum blood collection tube is in contact with air, and if microorganisms exist on the surface of the vacuum blood collection tube in the production process, the propagation condition of the microorganisms cannot be controlled in the long-time transportation process, so that the situation that the propagation of the microorganisms exceeds the standard in the background technology can be caused, the preset optimal dose is not matched with the actual microorganism number, and the radiation sterilization effect is not ideal. The existence of the antibacterial membrane can ensure that the propagation speed of microorganisms on the outer surface is limited in the transportation process, so that the difference of the microorganisms on the outer surface of the vacuum blood collection tube before and after transportation is small, and the vacuum blood collection tube can be completely sterilized under the preset optimal irradiation dose.

(2) During the blood collection process of the vacuum blood collection tube, the blood flows into the vacuum blood collection tube due to the internal negative pressure, the outer surface of the vacuum blood collection tube is exposed in the air, and particularly in the occasions such as hospitals and the like, the bacteria in the whole air are more; generally, only the sterility of the interior of the vacuum blood collection tube is ensured, and external bacteria are ignored; and medical personnel need touch the vacuum test tube outside in operation process, can continue to observe operations such as equipment after touching, and remove operation process is observed in frequent touching, can lead to the fact slight influence to the inside sample of vacuum test tube to make the sample testing result deviate. The bacteriostatic membrane outside the vacuum blood collection tube can ensure that bacteria outside the vacuum blood collection tube are propagated, the bacteria cannot be propagated in large batch even if the outer surface is infected with the bacteria in the using process, and the influence of external microorganisms on samples inside the blood collection tube is reduced as much as possible.

The principle of vacuum test tube is that inside negative pressure is kept at the in-process of drawing blood for blood flows into the blood sampling tube smoothly, if the leakproofness of vacuum test tube is not good, then can make inside negative pressure run off in long-term transportation and storage process, and then can't reach the purpose of blood sampling. In the prior art, after the production and manufacture of the vacuum blood collection tube are finished, a special process is needed for detecting the sealing performance of the blood collection tube. The invention skillfully combines the sealing performance detection and the formation process of the antibacterial film, and provides a new sealing performance detection idea in the antibacterial film coating process; the vacuum blood collection tube with poor sealing performance can be eliminated while the sterilization effect is ensured, and the detection efficiency of the vacuum blood collection tube is further improved.

The bacteriostatic solution comprises the bighead atractylodes rhizome extract, aloin, silver sulfate, a surfactant and lactic acid, wherein the bighead atractylodes rhizome extract, the aloin and silver ions have a bactericidal effect, and the three are matched and practical to play an obvious bacteriostatic effect. Lactic acid is added into the bacteriostatic solution to make the solution acidic, so that subsequently added silver ions are more easily dissolved; the surfactant in the antibacterial solution is polyvinylpyrrolidone, and the polyvinylpyrrolidone can be mixed with silver ions, so that the silver ions are more stable in the solution and are not easy to separate out.

The radiation sterilization process according to the invention is further illustrated by the following specific examples: it should be noted that the irradiation dose in the present invention is the best dose determined in advance according to the material and preparation process of the vacuum blood collection tubes of the same batch, and the specific determination method can be performed by methods in the prior art, which are not described in detail herein. The optimal irradiation dose of the vacuum blood collection tube used in the following examples is 10 kGy; for other batches of vacuum blood collection tubes, the optimal irradiation dose can be specifically determined, and the range is generally kept between 8 and 20 kGy.

Example 1

A radiation sterilization method of a vacuum blood collection tube comprises the following steps:

s01: soaking the vacuum blood collection tube in an antibacterial solution; the preparation method of the bacteriostatic solution specifically comprises the following steps:

s011: adding 5kg of Atractylodis rhizoma extract and 8kg of aloin into 83.5kg of deionized water, and stirring to obtain extractive solution; wherein, the white atractylodes rhizome extract adopted in the invention is the white atractylodes rhizome extract provided by Xian Yunuo bioengineering limited company; the aloin used in the invention is aloin powder provided by Hubei Shishun Biotech Co.

S012: adding 2kg of polyvinylpyrrolidone and 0.5kg of lactic acid into the extracting solution, and uniformly stirring;

s013: adding 1kg of silver sulfate solution and stirring uniformly to form the antibacterial solution.

And synchronously detecting the sealing performance of the vacuum blood collection tube. And completely pressing the vacuum blood collection tube into the liquid tank by using a pressing plate, keeping for 24h, taking out, and filling the antibacterial solution into the liquid tank. If the vacuum blood collection tube is filled with liquid, the sealing performance of the vacuum blood collection tube does not reach the standard, and the vacuum blood collection tube is regarded as an unqualified product.

S02: drying the soaked vacuum blood collection tube in an oven at 60 ℃; so that a layer of antibacterial film is formed on the outer surface of the vacuum blood collection tube;

s03: packaging the vacuum blood collection tube;

s04: transporting the vacuum blood collection tube to an irradiation chamber;

s05: sterilizing the packed vacuum blood collection tube by irradiation, wherein⁶⁰And (5) carrying out irradiation treatment on the cobalt gamma rays and outputting the cobalt gamma rays, wherein the irradiation dose is 10 kGy.

Example 2

A radiation sterilization method of a vacuum blood collection tube comprises the following steps:

s01: soaking the vacuum blood collection tube in an antibacterial solution; the preparation method of the bacteriostatic solution specifically comprises the following steps:

s011: adding 8kg of the bighead atractylodes rhizome extract and 5kg of aloin into 81.5kg of deionized water, and uniformly stirring to form an extracting solution;

s012: adding 4kg of polyvinylpyrrolidone and 1kg of lactic acid into the extracting solution, and uniformly stirring;

s013: adding 0.5kg of silver sulfate solution and stirring uniformly to form the antibacterial solution.

And synchronously detecting the sealing performance of the vacuum blood collection tube. And completely pressing the vacuum blood collection tube into the liquid tank by using a pressing plate, keeping for 48h, taking out, and filling the antibacterial solution into the liquid tank. If the vacuum blood collection tube is filled with liquid, the sealing performance of the vacuum blood collection tube does not reach the standard, and the vacuum blood collection tube is regarded as an unqualified product.

S02: drying the soaked vacuum blood collection tube in an oven at 80 ℃; so that a layer of antibacterial film is formed on the outer surface of the vacuum blood collection tube;

s03: packaging the vacuum blood collection tube;

s04: transporting the vacuum blood collection tube to an irradiation chamber;

s05: sterilizing the packed vacuum blood collection tube by irradiation, wherein⁶⁰And (5) carrying out irradiation treatment on the cobalt gamma rays and outputting the cobalt gamma rays, wherein the irradiation dose is 10 kGy.

Example 3

A radiation sterilization method of a vacuum blood collection tube comprises the following steps:

s01: soaking the vacuum blood collection tube in an antibacterial solution; the preparation method of the bacteriostatic solution specifically comprises the following steps:

s011: adding 7kg of bighead atractylodes rhizome extract and 6kg of aloin into 82.4kg of deionized water, and uniformly stirring to form an extracting solution;

s012: adding 3kg of polyvinylpyrrolidone and 0.8kg of lactic acid into the extracting solution, and uniformly stirring;

s013: adding 0.8kg of silver sulfate solution and stirring uniformly to form the antibacterial solution.

And synchronously detecting the sealing performance of the vacuum blood collection tube. And completely pressing the vacuum blood collection tube into the liquid tank by using a pressing plate, keeping for 24h, taking out, and filling the antibacterial solution into the liquid tank. If the vacuum blood collection tube is filled with liquid, the sealing performance of the vacuum blood collection tube does not reach the standard, and the vacuum blood collection tube is regarded as an unqualified product.

S02: drying the soaked vacuum blood collection tube in an oven at 70 ℃; so that a layer of antibacterial film is formed on the outer surface of the vacuum blood collection tube;

s03: packaging the vacuum blood collection tube;

s04: transporting the vacuum blood collection tube to an irradiation chamber;

s05: sterilizing the packed vacuum blood collection tube by irradiation, wherein⁶⁰And (5) carrying out irradiation treatment on the cobalt gamma rays and outputting the cobalt gamma rays, wherein the irradiation dose is 10 kGy.

Comparative example 1

The comparative example differs from example 3 only in that: in step S01, the vacuum blood collection tube is soaked in deionized water.

Comparative example 2

The comparative example differs from example 3 only in that: the bacteriostatic solution in step S01 does not contain silver nitrate.

Comparative example 3

The comparative example differs from example 3 only in that: the bacteriostatic solution does not contain the extract of atractylodes macrocephala in step S01.

Comparative example 4

The comparative example differs from example 3 only in that: the bacteriostatic solution in step S01 does not contain aloin.

Experimental example 1

In the use of examples 1-3 and comparative examples 1-4 method irradiation sterilization vacuum blood collection tube after random 10 samples, unpack, placed in the same environment for 5 days. Preparing culture dishes (7 groups, 10 culture dishes in each group) containing the same type and volume of beef extract agar culture medium, completely inserting the vacuum blood collection tube into the beef extract agar culture medium (the insertion refers to the insertion of the outer surface), placing the culture dishes in a 37 ℃ constant temperature incubator for culturing for 4 days, counting the number of colonies in each group of culture medium, and taking the average as the final result. The results of measuring the average number of colonies are shown in Table 1.

TABLE 1 results of colony tests on the outer surface of different vacuum blood collection tubes

Item	Number of colonies
		Example 1	17
Example 2	18
		Example 3	17
Comparative example 1	51
		Comparative example 2	34
Comparative example 3	37
		Comparative example 4	38

The existence of the antibacterial membrane can inhibit the bacterial reproduction of the outer surface of the vacuum blood collection tube, and the vacuum blood collection tube after irradiation sterilization is completely sterile; when the completely sterile vacuum blood collection tube is placed for a period of time after being unpacked and packaged, the outer surface of the vacuum blood collection tube produces strains due to microorganisms in the air; and then the outer surface of the placed vacuum blood collection tube is subjected to colony culture, and the number of colonies on the outer surface reflects the inhibition effect of the antibacterial film on the growth of the strains to a certain extent. If no antibacterial film is added in the comparative example 1, the number of colonies on the outer surface of the vacuum blood collection tube is approximately three times that of the colonies in the examples 1-3, which shows that the antibacterial film can obviously inhibit the growth of strains;

the bacteriostatic solutions in comparative examples 2-4 lack silver nitrate, the extract of rhizoma atractylodis macrocephalae and aloin respectively, the bacteriostatic effect is obviously inferior to that in example 3, and the number of colonies after culture is basically 2 times of that in example 3; the colony number in the comparative examples 3 and 4 is larger than that in the comparative example 2, which fully shows that the bacteriostatic effect of the rhizoma atractylodis macrocephalae extract and the aloin in the antibacterial film is larger than that of silver ions.

Various other modifications and changes may be made by those skilled in the art based on the above-described technical solutions and concepts, and all such modifications and changes should fall within the scope of the claims of the present invention.